Lansoprazole combined with Ursodiol

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
International Normalised Ratio Increased 6/30/2004 53 9/12/2005 Pharmacist United States
Primary
Concomitant
Liver Function Test Abnormal 12/18/2004 38 9/12/2005 Pharmacist United States
Primary
Concomitant
Liver Function Test Abnormal 11/1/2004 61 9/12/2005 Pharmacist United States
Primary
Concomitant
International Normalised Ratio Increased 8/24/2004 65 9/12/2005 Physician United States
Primary
Concomitant
International Normalised Ratio Increased 7/22/2004 9/12/2005 Physician United States
Primary
Concomitant
Transient Ischaemic Attack Other Serious 2/1/2004 59 Female 1/26/2006 Other Health Professional United Kingdom
Primary
Concomitant
Tachypnoea 5/4/2006 16 Female 144 lb 5/12/2006 Pharmacist United States
Primary
Concomitant
Tachypnoea Required Intervention 5/4/2006 16 Female 144 lb 5/18/2006 Physician United States
Primary
Concomitant
Tachypnoea Required Intervention 5/4/2006 16 Female 144 lb 6/12/2006 Physician United States
Primary
Concomitant
Therapeutic Product Contamination Required Intervention 5/4/2006 16 Female 144 lb 6/23/2006 Physician United States
Primary
Concomitant
Stem Cell Transplant Hospitalization 9/2/2006 60 Male 191 lb 9/6/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Therapy Non-responder Hospitalization 9/21/2006 59 Male 12/19/2006 Japan
Primary
Secondary
Platelet Count Decreased Other Serious 7/6/2006 60 Female 97 lb 12/22/2006 Japan
Primary
Concomitant
Tumour Lysis Syndrome Other Serious 10/14/2006 11 Female 60 lb 1/4/2007 Physician Canada
Primary
Concomitant
Pulmonary Alveolar Haemorrhage Life Threatening 10/19/2006 54 Female 2/21/2007 Japan
Primary
Secondary
Concomitant
Anaemia Haemolytic Autoimmune Other Serious 5/17/2007 Physician United States
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Life Threatening 4/9/2007 19 Male 164 lb 5/24/2007 Physician United States
Primary
Secondary
Concomitant
Ventricular Tachycardia Life Threatening 4/9/2007 19 Male 167 lb 6/4/2007 Physician United States
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Life Threatening 4/9/2007 19 Male 167 lb 6/7/2007 Physician United States
Primary
Secondary
Concomitant
Jaundice Hospitalization 6/27/2007 Male 7/17/2007 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Transaminases Increased Hospitalization 6/27/2007 41 Male 7/9/2007 Italy
Primary
Secondary
Concomitant
Jaundice Hospitalization 6/27/2007 Male 7/25/2007 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Urticaria Hospitalization 5/23/2007 7 Female 47 lb 7/18/2007 Other Health Professional United States
Primary
Concomitant
Transaminases Increased Hospitalization 6/27/2007 41 Male 7/19/2007 Italy
Primary
Secondary
Concomitant
Urticaria Hospitalization 5/23/2007 7 Female 47 lb 8/6/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Colitis Ulcerative Hospitalization 1/7/2007 21 Male 114 lb 2/1/2007 Pharmacist United States
Primary
Concomitant
Vomiting Hospitalization 5/23/2007 7 Female 47 lb 9/17/2007 United States
Primary
Secondary
Concomitant
Staphylococcal Infection Other Serious 7/11/2007 Male 243 lb 9/18/2007 Pharmacist United States
Primary
Secondary
Concomitant
Renal Impairment Other Serious 3/29/2007 69 Male 135 lb 9/21/2007 Other Health Professional Japan
Primary
Concomitant
Red Blood Cell Count Decreased Other Serious 6/1/2006 86 Male 131 lb 10/6/2007 Japan
Primary
Concomitant
Sepsis Other Serious 5/25/2007 76 Female 11/5/2007 Physician Japan
Primary
Concomitant
Pancytopenia Hospitalization 6/8/2007 59 Female 12/14/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Platelet Count Decreased Life Threatening 11/6/2007 Female 115 lb 11/15/2007 Pharmacist United States
Primary
Concomitant
Pyrexia Hospitalization 11/13/2007 Male 24 lb 1/15/2008 Physician United States
Primary
Concomitant
Metastases To Liver Death 70 Male 1/29/2008 Japan
Primary
Concomitant
Pleural Effusion Hospitalization 6/6/2007 59 Female 2/5/2008 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Hospitalization 12/7/2004 Male 178 lb 3/3/2008 Physician United States
Primary
Concomitant
Respiratory Failure Hospitalization 11/13/2007 Male 24 lb 4/2/2008 Physician United States
Primary
Concomitant
Respiratory Failure Hospitalization 11/13/2007 Male 24 lb 4/4/2008 Physician United States
Primary
Concomitant
Shock Other Serious 2/1/2008 Male 4/8/2008 Physician Japan
Primary
Concomitant
Shock Other Serious 2/1/2008 Male 4/22/2008 Physician Japan
Primary
Concomitant
Shock Other Serious 2/1/2008 Male 5/1/2008 Physician Japan
Primary
Concomitant
Sepsis Other Serious 5/25/2007 76 Female 5/5/2008 Physician Japan
Primary
Concomitant
Sepsis Other Serious 5/25/2007 76 Female 5/19/2008 Physician Japan
Primary
Secondary
Concomitant
Shock Other Serious 2/1/2008 Male 7/3/2008 Physician Japan
Primary
Concomitant
Hepatitis Hospitalization 7/31/2007 Female 183 lb 8/12/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Septic Shock Life Threatening 5/19/2008 Male 9/4/2008 Physician United States
Primary
Secondary
Concomitant
Septic Shock Life Threatening 5/19/2008 56 Male 9/12/2008 Physician United States
Primary
Secondary
Concomitant
Septic Shock Life Threatening 5/19/2008 56 Male 9/30/2008 Physician United States
Primary
Secondary
Concomitant
Ventricular Tachycardia Required Intervention 4/12/2007 19 Male 165 lb 10/10/2008 Physician United States
Primary
Secondary
Concomitant
Septic Shock Life Threatening 5/19/2008 56 Male 10/21/2008 Physician United States
Primary
Secondary
Concomitant
Vomiting Hospitalization 9/14/2008 64 Female 10/24/2008 Physician Japan
Primary
Secondary
Concomitant
Lethargy Hospitalization 10/20/2008 48 Female 10/20/2008 Pharmacist United States
Primary
Concomitant
White Blood Cell Count Decreased Required Intervention 4/12/2007 19 Male 165 lb 11/18/2008 Physician United States
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 11/13/2007 Male 24 lb 4/3/2009 Physician United States
Primary
Concomitant
Metastases To Liver Death 70 Male 123 lb 4/9/2009 Japan
Primary
Concomitant
Muscular Weakness Hospitalization 12/11/2008 54 Female 6/10/2009 Japan
Primary
Secondary
Concomitant
Serum Ferritin Increased Other Serious 2/21/2008 59 Female 6/17/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Serum Ferritin Increased Other Serious 2/21/2008 59 Female 6/29/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Hepatic Failure Death 2/23/2009 52 Male 117 lb 6/29/2009 Physician Japan
Primary
Concomitant
Serum Ferritin Increased Other Serious 2/21/2008 59 Female 7/10/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Hepatic Function Abnormal Hospitalization 5/31/2008 47 Male 7/31/2009 Japan
Primary
Concomitant
Renal Impairment Other Serious 3/29/2007 69 Male 135 lb 9/17/2009 Japan
Primary
Concomitant
Wound Infection Hospitalization 29 Female 276 lb 9/29/2009 United States
Primary
Concomitant
Epistaxis Other Serious 6/5/2008 47 Male 10/9/2009 Physician Japan
Primary
Concomitant
Vomiting Hospitalization 9/1/2009 5 Female 47 lb 10/29/2009 Other Health Professional United States
Primary
Concomitant
Non-small Cell Lung Cancer Life Threatening 9/21/2009 62 Male 11/10/2009 Other Health Professional Japan
Primary
Concomitant
Malignant Neoplasm Progression Life Threatening 9/21/2009 62 Male 12/4/2009 Physician Japan
Primary
Concomitant
Oxygen Saturation Decreased Hospitalization 12/14/2009 Male 101 lb 12/24/2009 Physician United States
Primary
Secondary
Concomitant
Pulmonary Hypertension Death 12/26/2007 49 Female 12/20/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Methaemoglobinaemia Hospitalization 12/14/2009 Male 101 lb 1/5/2010 Physician United States
Primary
Secondary
Concomitant
Multi-organ Failure Death 10/1/2009 52 Male 12/22/2009 Physician Japan
Primary
Concomitant
Traumatic Fracture Hospitalization 12/11/2007 41 Female 12/30/2009 Physician Japan
Primary
Secondary
Concomitant
Methaemoglobinaemia Hospitalization 12/14/2009 Male 101 lb 1/11/2010 Physician United States
Primary
Secondary
Concomitant
Disseminated Cytomegaloviral Infection Life Threatening 2/23/2009 52 Male 126 lb 12/31/2009 Physician Japan
Primary
Concomitant
No Therapeutic Response Death 10/1/2009 52 Male 132 lb 1/29/2010 Physician Japan
Primary
Concomitant
Hepatic Failure Life Threatening 2/23/2009 52 Male 126 lb 2/16/2010 Physician Japan
Primary
Concomitant
Ventricular Tachycardia Required Intervention 4/12/2007 19 Male 165 lb 3/2/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Herpes Simplex Hospitalization 4/30/2010 75 Male 134 lb 5/28/2010 Physician United States
Primary
Concomitant
Pneumonia Cytomegaloviral Life Threatening 2/14/2009 52 Male 126 lb 4/20/2010 Physician Japan
Primary
Concomitant
Lower Respiratory Tract Infection Other Serious 5/14/2010 78 Male 165 lb 6/14/2010 Other Health Professional United Kingdom
Primary
Concomitant
Lower Respiratory Tract Infection Hospitalization 5/14/2010 78 Male 165 lb 6/15/2010 Other Health Professional United Kingdom
Primary
Concomitant
Lower Respiratory Tract Infection Other Serious 5/14/2010 78 Male 165 lb 6/21/2010 Other Health Professional United Kingdom
Primary
Concomitant
Lower Respiratory Tract Infection Other Serious 5/14/2010 78 Male 165 lb 6/24/2010 Other Health Professional United Kingdom
Primary
Concomitant
Lower Respiratory Tract Infection Other Serious 78 Male 6/24/2010 Consumer United Kingdom
Primary
Concomitant
Muscle Atrophy Other Serious 1/1/2008 70 Male 154 lb 7/21/2010 Other Health Professional United Kingdom
Primary
Concomitant
Muscle Atrophy Other Serious 1/1/2008 70 Male 154 lb 7/26/2010 United Kingdom
Primary
Concomitant
Muscle Atrophy Other Serious 1/1/2008 70 Male 154 lb 8/2/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Muscle Atrophy Other Serious 1/1/2008 Male 154 lb 8/3/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Muscle Atrophy Other Serious 1/1/2008 70 Male 154 lb 7/29/2010 Other Health Professional
Primary
Concomitant
Muscle Atrophy Other Serious 1/1/2008 154 lb 7/29/2010 United Kingdom
Primary
Concomitant
Muscle Atrophy Other Serious 1/1/2008 Male 154 lb 7/30/2010 Other Health Professional United Kingdom
Primary
Concomitant
Systemic Lupus Erythematosus Hospitalization 2/1/2009 56 Female 8/9/2010 Japan
Primary
Secondary
Concomitant
Staphylococcal Sepsis Hospitalization 3/15/2009 38 Male 128 lb 9/30/2010 Physician Japan
Primary
Concomitant
Tachycardia Hospitalization 4/28/2010 19 Female 115 lb 11/8/2010 Physician Japan
Primary
Concomitant
Weight Increased Other Serious 1/17/2010 Male 168 lb 11/22/2010 Physician Japan
Primary
Concomitant
Vomiting Other Serious 6/12/2010 12/1/2010 Consumer Japan
Primary
Concomitant
Neutrophil Count Decreased Death 76 Male 12/20/2010 Physician Japan
Primary
Secondary
Concomitant
Sepsis Life Threatening 7/28/2010 30 Female 99 lb 1/6/2011 Physician Japan
Primary
Concomitant
Therapeutic Response Decreased Other Serious 7/1/2009 48 Female 115 lb 1/6/2011 Physician Japan
Primary
Concomitant
Graft Versus Host Disease Hospitalization 11/20/2009 41 Male 126 lb 1/10/2011 Physician Japan
Primary
Secondary
Concomitant
Blood Pressure Increased Other Serious 8/9/2009 48 Female 115 lb 1/10/2011 Physician Japan
Primary
Secondary
Concomitant
Skin Cancer Other Serious 10/1/2009 51 Female 95 lb 2/11/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Cardiac Failure Hospitalization 5/17/2010 2/18/2011 Physician Japan
Primary
Concomitant
Actinic Keratosis Other Serious 51 Female 2/18/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Cystitis Haemorrhagic Death 10/14/2010 49 Male 2/23/2011 Physician United States
Primary
Concomitant
Abdominal Distension Other Serious 10/7/2010 49 Male 3/10/2011 Other Health Professional United States
Primary
Concomitant
Vasculitis Hospitalization 2/24/2011 66 Male 5/10/2011 Physician Japan
Primary
Concomitant
Weight Increased Hospitalization 1/17/2010 55 Male 168 lb 6/7/2011 Physician Japan
Primary
Secondary
Concomitant
Serum Sickness Death 7/16/2010 68 Male 121 lb 6/16/2011 Physician Japan
Primary
Secondary
Concomitant
Viral Haemorrhagic Cystitis Death 7/28/2010 30 Female 99 lb 6/22/2011 Physician Japan
Primary
Concomitant
Cytomegalovirus Infection Other Serious 4/18/2011 58 Male 6/22/2011 Physician Japan
Primary
Secondary
Concomitant
Graft Versus Host Disease Hospitalization 5/25/2010 23 Female 73 lb 6/23/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Skin Other Serious 7/21/2010 7/5/2011 Physician Japan
Primary
Secondary
Concomitant
B-cell Lymphoma Other Serious 4/14/2011 58 Male 143 lb 7/5/2011 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 10/7/2010 49 Male 6/29/2011 Other Health Professional United States
Primary
Concomitant
Lymphocyte Count Decreased Life Threatening 4/14/2011 58 Male 143 lb 7/20/2011 Physician Japan
Primary
Secondary
Concomitant
Gastric Cancer Other Serious 6/24/2011 72 Male 116 lb 7/27/2011 Physician Japan
Primary
Secondary
Concomitant
Insomnia Other Serious 11/23/2010 62 Female 108 lb 8/8/2011 Physician Japan
Primary
Concomitant
Haematocrit Decreased Hospitalization 2/1/2010 38 Female 132 lb 8/9/2011 Physician Japan
Primary
Concomitant
Platelet Count Decreased Other Serious 2/24/2011 66 Male 132 lb 8/31/2011 Physician Japan
Primary
Concomitant
Epstein-barr Virus Associated Lymphoproliferative Disorder Life Threatening 7/28/2010 30 Female 99 lb 9/28/2011 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 1/1/2011 4 Male 37 lb 10/11/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Haematemesis Other Serious 4 Male 38 lb 10/14/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Anticoagulation Drug Level Above Therapeutic Other Serious 67 Male 110 lb 10/20/2011 Other Health Professional Japan
Primary
Concomitant
Interacting
Interstitial Lung Disease Hospitalization 6/1/2011 80 Male 10/19/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Life Threatening 6/24/2010 29 Female 99 lb 10/31/2011 Physician Japan
Primary
Concomitant
Cytomegalovirus Test Positive Other Serious 7/19/2011 51 Male 11/2/2011 Physician Japan
Primary
Concomitant
Dyspnoea Hospitalization 6/1/2011 80 Male 10/30/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Blood Glucose Increased Other Serious 2/11/2011 55 Female 123 lb 11/11/2011 Physician Japan
Primary
Concomitant
Fall Other Serious 6/12/2010 70 Male 154 lb 11/23/2011 Physician Japan
Primary
Concomitant
Hypoxia Other Serious 5/18/2011 50 Female 84 lb 11/23/2011 Physician Japan
Primary
Concomitant
Infection Disability 4/28/2010 19 Female 115 lb 11/29/2011 Physician Japan
Primary
Concomitant
Gastric Cancer Other Serious 6/21/2011 72 Male 116 lb 11/30/2011 Japan
Primary
Secondary
Concomitant
Sinusitis Hospitalization 10/9/1996 23 Female 276 lb 11/18/2011 Lawyer United States
Primary
Secondary
Concomitant
Hypoaesthesia Hospitalization 1/1/2010 48 Female 128 lb 12/2/2011 Physician United States
Primary
Concomitant
Hypoalbuminaemia Other Serious 5/24/2011 50 Male 128 lb 12/7/2011 Physician Japan
Primary
Concomitant
Viral Haemorrhagic Cystitis Death 6/24/2010 29 Female 99 lb 12/8/2011 Other Health Professional Japan
Primary
Concomitant
Death Death Female 124 lb 12/12/2011 Physician Japan
Primary
Concomitant
Bedridden Other Serious 10/4/2011 49 Male 12/12/2011 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Death 2/7/2009 57 Male 139 lb 12/14/2011 Physician Japan
Primary
Concomitant
Cardiac Failure Acute Death 12/4/2011 73 Female 124 lb 12/21/2011 Physician Japan
Primary
Concomitant
Blood Potassium Increased Death 6/25/2009 35 Male 130 lb 12/16/2011 Physician Japan
Primary
Concomitant
Staphylococcal Sepsis Disability 3/14/2011 25 Male 123 lb 1/3/2012 Physician Japan
Primary
Concomitant
Deep Vein Thrombosis Hospitalization 12/9/2011 36 Female 112 lb 1/3/2012 Physician Japan
Primary
Concomitant
Bedridden Hospitalization 10/12/2011 49 Male 1/4/2012 Physician Japan
Primary
Concomitant
Pleural Effusion Life Threatening 10/12/2011 49 Male 1/5/2012 Physician Japan
Primary
Concomitant
Parkinsonism Other Serious 8/6/2011 79 Male 12/27/2011 Physician Japan
Primary
Secondary
Concomitant
Tremor Other Serious 8/6/2011 79 Male 1/13/2012 Physician Japan
Primary
Secondary
Concomitant
Deep Vein Thrombosis Other Serious 12/9/2011 36 Female 111 lb 1/30/2012 Physician Japan
Primary
Concomitant

Drug Data